The following data is part of a premarket notification filed by Neurovision, Inc. with the FDA for Aa-1 System.
Device ID | K012530 |
510k Number | K012530 |
Device Name: | AA-1 SYSTEM |
Classification | Haploscope |
Applicant | NEUROVISION, INC. 12300 TWINBROOK PKWY. SUITE 230 Rockville, MD 20852 |
Contact | Richard E Lippman |
Correspondent | Richard E Lippman NEUROVISION, INC. 12300 TWINBROOK PKWY. SUITE 230 Rockville, MD 20852 |
Product Code | HJT |
CFR Regulation Number | 886.1340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-08-06 |
Decision Date | 2001-08-31 |
Summary: | summary |